Status: Finalised First registered on: 01/08/2016
Last updated on: 28/03/2018
1. Study identification
EU PAS Register NumberEUPAS14528
Official titlePost-Authorisation Safety Study (PASS) for Flupirtine – Effect of Risk Minimisation Measures in Germany
Study title acronym
Study typeObservational study
Brief description of the studyThis is a retrospective cohort study with pre-post design (before and after implementation of risk minimisation measures) using a longitudinal patient level Electronic Medical Records (EMR) database and a longitudinal patient level prescription database for Germany.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Dr
Last name von Bredow
First name Dorothea
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed28/10/201428/10/2014
Start date of data collection01/07/201601/07/2016
Start date of data analysis15/07/2016
Date of interim report, if expected
Date of final study report31/12/201612/12/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesHormosan Pharma GmbH100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Thun
First name Barbara
Address line 1IMS HEALTH GmbH & Co. OHG
Address line 2Erika-Mann-Str. 5 
Address line 3 
CityMünchen 
Postcode80636 
CountryGermany
Phone number (incl. country code)49894579126431 
Alternative phone number 
Fax number (incl. country code)49894579127400 
Email address bthun@de.imshealth.com
Public Enquiries
Title Ms 
Last name Thun 
First name Barbara 
Address line 1IMS HEALTH GmbH & Co. OHG 
Address line 2Erika-Mann-Str. 5 
Address line 3 
CityMünchen 
Postcode80636 
CountryGermany 
Phone number (incl. country code)49894579126431 
Alternative phone number 
Fax number (incl. country code)49894579127400 
Email address bthun@de.imshealth.com 
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